St Louis Cancer Care

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the performance verification procedures for the Diatron Abacus 3 CP analyzer and patient results and interview with the laboratory personnel manager, the laboratory failed to verify performance specifications prior to reporting patient test results. Findings: 1. Review of the performance verification procedures for the Diatron Abacus 3 CP analyzer showed the laboratory failed to verify that the manufacturer's reference intervals (normal ranges) were appropriate for the laboratory's patient population for the analytes: white blood cell (WBC), red blood cell (RBC), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red blood cell distribution width (RDW), platelets, mean platelet volume (MPV), percent granulocytes, percent lymphocytes, percent monocytes, absolute granulocytes, absolute lymphocytes, and absolute monocytes prior to the beginning of patient testing in June 2024. 2. The laboratory performs approximately 5,805 hematology patient tests annually. 3. Interview with the laboratory personnel manager on July 8, 2026 at 11:30 AM confirmed the laboratory failed to verify performance specifications prior to reporting patient test results. D6013 LABORATORY DIRECTOR RESPONSIBILITIES Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on review of verification procedures and patient reports and interview with the laboratory personnel manager, the laboratory director (LD) failed to ensure that verification procedures for the Diatron Abacus 3 CP analyzer were adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method prior to patient testing. Findings: 1. Review of the Diatron Abacus 3 CP analyzer verification procedures showed no documentation to show verification procedures for the Diatron Abacus 3 CP analyzer were adequate, reviewed and approved by the laboratory director for accuracy, precision, reportable range of test results, and verification that the manufacturer's reference intervals (normal values) were appropriate for the laboratory's patient population for the analytes: white blood cell (WBC), red blood cell (RBC), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red blood cell distribution width (RDW), platelets, mean platelet volume (MPV), percent granulocytes, percent lymphocytes, percent monocytes, absolute granulocytes, absolute lymphocytes, and absolute monocytes prior to the beginning of patient testing in June 2024. 2. The laboratory performs approximately 5,805 hematology patient tests annually. 3. Interview with the laboratory personnel manager on July 8, 2026 at 11:30 AM confirmed the LD failed to ensure that verification procedures for the Diatron Abacus 3 CP analyzer were adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method prior to patient testing. -- 2 of 2 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of 2020 and 2021 hematology proficiency testing (PT) results reported to the CLIA database by the PT provider and phone interview with RN, the laboratory failed to successfully participate in PT. See tag D2130 unsatisfactory performance in two out of three consecutive testing events for the same analyte. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of 2020/2021 hematology proficiency test (PT) performance, which was reported to the CLIA data base by the PT provider, and phone interview with the RN revealed that the laboratory failed to achieve satisfactory performance for analyte hematocrit (HCT) in two out of three consecutive testing events. Findings: 1. The laboratory obtained an unsatisfactory 20 percent for the HCT analyte on the second testing event of 2020. 2. The laboratory obtained an unsatisfactory 20 percent for the HCT analyte on the first testing event of 2021. 3. Phone interview with the RN on April 6, 2021 at 11:00 AM confirmed the laboratory failed to achieve satisfactory performance for HCT in two out of three consecutive PT events. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of policies and interview with the lab supervisor the laboratory failed to follow policy and review 10 of 24 months of hematology quality control (QC) and one of six proficiency testing ( PT) for 2016 and 2017. Findings: 1. Laboratory policy states "all MLE reports, proficiency testing, or any lab evaluation reports will be signed by" lab director or technical consultant "after reviewing and taking any